External Audit CAR on Record Control?

A

amanbhai

#1
Last week we have been audited externally by the accreditation body. One of the NCs is our record is not controlled! I am also an auditor and want to know the specific requirement, auditor mentioned the nonconformance against 4.3 of ISO 17025:2005. I am not satisfied.
For my our learning and increase competence and understanding, any comment or assistance is appreciated.
:thanks:
 
Last edited by a moderator:
Elsmar Forum Sponsor
T

Ted Schmitt

#2
What was the exact wording the auditor used?

Which record is not controlled? Do you have it identified that it needs control and did not control it or was it a record that the auditor thought best to be controlled?

Are you the only one not agreeing with the auditor or is your management also not agreeing?
 
P

Polly Pure Bread

#3
If it did not meet the requirements, an explanation of where it did not and what actions are necessary for it to meet them should come from the auditor and discussed with personnel involved. Ideally, the closing meeting offers an opportunity to reach the auditee through direct verbal communication prior to final written report.
 
A

amanbhai

#4
What was the exact wording the auditor used?

Which record is not controlled? Do you have it identified that it needs control and did not control it or was it a record that the auditor thought best to be controlled?

Are you the only one not agreeing with the auditor or is your management also not agreeing?
the exact working are "Some quality documents like preventive matintenance plan 2009, lab staff list (for training on measurement uncertainty, dated:23-04-2009) and trainings schedule of lab personnel for year 2009 are not controlled."
We did identified some of the records. however, all records are not identified for controlling.
We the management has reservation about this finding.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#5
The finding may or may not be justified, but I would have documented it against Clause 4.13.1 or 4.13.2 (Quality Records or Technical Records).

The forms would be documented against Clause 4.3 in my opinion.
 
#6
the exact working are "Some quality documents like preventive matintenance plan 2009, lab staff list (for training on measurement uncertainty, dated:23-04-2009) and trainings schedule of lab personnel for year 2009 are not controlled."
We did identified some of the records. however, all records are not identified for controlling.
We the management has reservation about this finding.
You appear to be confusing the control of documents with the control of records. From what has been written, this is clearly a non-conformity, since each of these is a document, not a record.

Having reservations appears (at least to me) to come from a lack of complete understanding of the requirements at your organization, not due to a poor non-conformity statement by the external auditor.

You might want to take this as an opportunity to learn more about your system and how it complies with ISO/IEC 17025.
 
A

amanbhai

#7
Yes, this NC has given me the oppertunity to learn my systems as well the ISO 17025.
I am still learning my system.
 
Thread starter Similar threads Forum Replies Date
A External Audit CAR when Internal Audit CAR is in process? General Auditing Discussions 34
L IATF external audit virtual (remote) IATF 16949 - Automotive Quality Systems Standard 13
R External Audit and Certificate prorogation due to the pandemic General Auditing Discussions 10
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
I What kind of wine best complements the Friday that you close out your external audit findings? Opinions are welcome. Coffee Break and Water Cooler Discussions 12
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
qualprod The Perfect audit? External Audit causes a significant negative impact in a company General Auditing Discussions 9
B How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done. IATF 16949 - Automotive Quality Systems Standard 7
B IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
P IATF checklist for External Supplier Audit IATF 16949 - Automotive Quality Systems Standard 9
J Ignoring a Failed Gage R&R and upcoming external audit IATF 16949 - Automotive Quality Systems Standard 22
B Integrating ISO 9001/27001 External Audits - Audit Time Reduced? Discounts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Corrective Action for External Audit NCMR (Procedure Not Followed) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Effectiveness Plan for CAPA initiated from External Audit US Food and Drug Administration (FDA) 3
P Is Internal and external audit of Account Department applicable to any ISO standard Internal Auditing 5
R Can a external auditor raise a finding that is already identified in Internal Audit ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Root Cause for "Simple" External Audit Findings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Internal Audit finding versus External Audit finding General Auditing Discussions 2
drgnrider Control of External Audit Notes and Documents Document Control Systems, Procedures, Forms and Templates 8
L Mock Audit by External Consultant (ISO 13485) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
R External Audit Attendees - Surveillance Audit Quality Manager and Management Related Issues 27
Q External ISO 14001 Audit in a Distribution Center ISO 14001:2015 Specific Discussions 3
R QMS changes before Annual External Audit Quality Manager and Management Related Issues 8
M External Audit Findings - TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
B Audit of equipment after certified external calibration... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M What to do during a Stage 1 External Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
D Having trouble with corrective action on external audit nonconformance Nonconformance and Corrective Action 8
V Most Common Internal/External Audit Observations on Risk Management ISO 14971 - Medical Device Risk Management 4
S Internal and External Audit Programme Implementation Internal Auditing 6
C No findings from External Audit - Should I be worried? General Auditing Discussions 7
K External Auditor asking for other Audit Findings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
S Dreading an Ineffective External Audit and the impact it will have on staff General Auditing Discussions 1
Chennaiite External Audit re-defined Imported Legacy Blogs 4
A Need to Audit an External Calibration Laboratory? - Customer Audit Finding Other Medical Device Regulations World-Wide 5
J Withdraw NCR Request - External QMS Audit is In Progress General Auditing Discussions 23
S Customer Audit needs to see External Supplier Management Procedure Supplier Quality Assurance and other Supplier Issues 7
B Critical Action Limits (CAL) for All Internal and External Audit Findings General Auditing Discussions 17
S External Audit Non-Conformance - Control Plan and Inspection Issues IATF 16949 - Automotive Quality Systems Standard 1
S External Auditor Findings when an Internal Audit found a Nonconformance Yesterday Document Control Systems, Procedures, Forms and Templates 11
Chennaiite Questions on the Scope of Remote Locations for the ISO/TS External Audit IATF 16949 - Automotive Quality Systems Standard 7
R ISO 9001 Internal Quality Audit by Consultants (External agency) Internal Auditing 5
A What happens if an External Audit NC (Nonconformance) is not closed in 90 days? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Escalation of an External Audit Nonconformance Nonconformance and Corrective Action 13
M Giving copy of external audit report to customer General Auditing Discussions 20
S External Audit - Nonconformance Root causes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
L Human Resources Officer is absent during an ISO 9001 External Audit General Auditing Discussions 17
P ISO 13485 Audit - EN 62366:2008 not in External Document File IEC 62366 - Medical Device Usability Engineering 1
E First external audit coming up, do I need to have performed Internal Audits already? Internal Auditing 15
L How to check for validity of registration scope during ISO9001:2008 external audit Quality Manager and Management Related Issues 3
L Preparation for the second year external audit. General Auditing Discussions 8

Similar threads

Top Bottom